Finch Therapeutics Announces Removal of FDA Clinical Hold on CP101 IND
April 28 2022 - 5:20PM
Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”)
(Nasdaq: FNCH), a clinical-stage microbiome therapeutics company
leveraging its Human-First Discovery® platform to develop a novel
class of orally administered biological drugs, today announced that
the U.S. Food and Drug Administration (FDA) has removed the
clinical hold on Finch’s investigational new drug (IND) application
for CP101. CP101 is the Company’s investigational orally
administered microbiome therapeutic which is in late-stage clinical
development for the prevention of recurrent C. difficile infection
(CDI). The FDA lifted the clinical hold following a review of
information Finch provided related to its SARS-CoV-2 screening
procedures and associated informed consent language.
“We are grateful that the FDA has completed its
review of the information we provided, and we are pleased that the
clinical hold on our CP101 IND has been lifted,” said Mark Smith,
PhD, Chief Executive Officer of Finch Therapeutics. “We look
forward to completing the additional activities that we believe
will enable us to proceed with enrollment in PRISM4, our Phase 3
study of CP101 in recurrent C. difficile infection, and we thank
our PRISM4 trial partners for their continued support and
dedication to serving patients who are battling recurrent C.
difficile infection.”
Finch expects to proceed with enrollment in PRISM4
after it completes certain manufacturing activities and quality
system updates related to the recently resolved clinical hold, and
submits for the FDA’s review and agreement the validation package
for one of its release tests and a PRISM4 protocol amendment. The
PRISM4 protocol amendment will implement changes to the algorithm
used to diagnose suspected CDI recurrences and revisions to the
planned statistical analysis. In parallel with these activities,
Finch will continue to work with its PRISM4 trial sites to prepare
for enrollment.
Finch plans to provide an update on the
anticipated timing of both its PRISM4 trial and its planned AUSPIRE
Phase 1b trial of FIN-211 in children with autism spectrum disorder
and significant gastrointestinal symptoms when the Company reports
its first quarter 2022 results.
About Finch Therapeutics Finch
Therapeutics is a clinical-stage microbiome therapeutics company
leveraging its Human-First Discovery® platform to develop a novel
class of orally administered biological drugs. With the
capabilities to develop both complete and targeted microbiome
therapeutics, Finch is advancing a rich pipeline of candidates
designed to address a wide range of unmet medical needs. Finch’s
lead candidate, CP101, is in late-stage clinical development for
the prevention of recurrent C. difficile infection and has received
Breakthrough Therapy and Fast Track designations from the U.S. Food
and Drug Administration. Finch is also developing FIN-211 for
children with autism spectrum disorder and significant
gastrointestinal symptoms. Finch has a partnership with Takeda
focused on the development of targeted microbiome therapeutics for
inflammatory bowel disease.
Human-First Discovery® is a registered trademark
of Finch Therapeutics Group, Inc.
Forward-Looking Statements: This
press release includes “forward-looking statements”. Words such as
“will,” “anticipates,” “believes,” “expects,” “intends,” “plans,”
“potential,” "projects,” “would” and "future" or similar
expressions are intended to identify forward-looking statements.
These forward-looking statements include, but are not limited to,
statements regarding Finch’s ability to complete additional
activities to enable it to proceed with enrollment in PRISM4,
including completion of certain manufacturing activities and
quality system updates and submission to the FDA’s satisfaction of
a PRISM4 protocol amendment and the validation package for one of
its release tests, its ability to continue working with PRISM4
trial sites to prepare for enrollment and its plans to provide an
update on the timing of the PRISM4 trial and the AUSPIRE trial.
Because such statements are subject to risks and uncertainties,
actual results may differ materially from those expressed or
implied by such forward-looking statements. These risks and
uncertainties include, among others: the risk that correspondence
from the FDA may require Finch to collect additional data or
information beyond what it currently expects; uncertainties
relating to regulatory applications and related filing and approval
timelines; Finch’s limited operating history and historical losses;
the possibility that Finch may be delayed in initiating, enrolling
or completing any clinical trials; unexpected regulatory actions or
delays, including requests for additional safety and/or efficacy
data or analysis of data, or government regulation generally; the
ability of Finch to comply with regulatory requirements or
experience unanticipated problems with any of its product
candidates; ongoing regulatory obligations and continued regulatory
review may result in significant additional expense to Finch and
Finch may be subject to penalties for failure to comply; Finch’s
ability to maintain patent and other intellectual property
protection and the possibility that Finch’s intellectual property
rights may be infringed, invalid or unenforceable or will be
threatened by third parties; Finch’s ability to qualify and scale
its manufacturing capabilities to support multiple global clinical
trials; Finch’s dependence on third parties in connection with
manufacturing, clinical trials and preclinical studies; and risks
relating to the impact and duration of the COVID-19 pandemic on
Finch’s business. These and other risks are described more fully in
Finch’s filings with the Securities and Exchange Commission
(“SEC”), including the section titled “Risk Factors” in Finch’s
Annual Report on Form 10-K for the year ended December 31, 2021
filed with the SEC on March 31, 2022, as well as discussions of
potential risks, uncertainties, and other important factors in
Finch’s other filings with the SEC. All forward-looking statements
contained in this press release speak only as of the date on which
they were made. Except to the extent required by law, Finch
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made.
Investor Contact: Stephen Jasper
Gilmartin Group (858) 525-2047 stephen@gilmartinir.com
Media Contact: Jenna Urban Berry
& Company Public Relations (212) 253-8881
jurban@berrypr.com
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